Lilly, on Wednesday, announced that it would not seek regulatory approval for itstreatment arzoxifene, because the drug failed to meet certain end points in Phase III clinical trials.
The good news is that the drug was successful in meeting the primary end point of the trial, dubbed â€œGENERATIONS.â€ According to a press release, arzoxifene met the primary end point by â€œsignificantly reducing the risk of vertebral fracture and invasive breast cancer in postmenopausal women.â€ However, the drug did not meet specific secondary end points, and patients receiving the drug reported more side effects than those taking a placebo.
Lilly compared the treatment to its current osteoporosis products, and chose not to submit the drug for FDA review. The results of the five-year study will be released some time in 2010.
“At Lilly, our goal is to provide innovative therapies that result in better patient outcomes,” stated M. Johnston Erwin, global brand development leader for the musculoskeletal platform at Lilly. “While arzoxifene met its primary efficacy objectives in this study, we are disappointed that the GENERATIONS data did not convincingly demonstrate that arzoxifene would represent a meaningful advancement in the treatment of osteoporosis.”
Lilly was banking on the success of the drug to boost its pipeline, but the companyâ€™s CEO commented in the release by pointing out that Lilly has more than 60 molecules in development.
â€œItâ€™s not that serious a problemâ€ for Lilly, Natixis Bleichroeder analyst Jon LeCroy told Bloomberg. â€œOsteoporosis is a very tough category right now, and there is tough competition with generics.â€
If approved, the drug would have been fighting it out with GSK, Merck, and Tevaâ€”all of which either have competing treatments in the osteoporosis market, or are looking to launch a product in that category in the near future.
Now Lilly must reach out to the trial locations currently treating patients with arzoxifene, and discontinue all medication.